Formulation Design and Troubleshooting of Dry Dosage Forms (Tablets and Capsules)

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This is a Core Course for the following Certification Track(s):

  • Certified Process Validation Professional (CPVP)™


    Course Description

    This two-day course will explain the principles of dosage form design and how poor decisions at the design stage result in unstable processes and problem products. Product design should begin with identification of critical process and material parameters, but all too often this stage of the development is rushed and product yield and quality are compromised. Rectifying these problems retrospectively can be difficult and expensive. “Right first time” is the key to success.

    This program will also identify the key elements of a successful product, along with some novel techniques which can be applied both as development and as troubleshooting tools. The course will benefit personnel working in formulation and product development, manufacturing, product support, and regulatory affairs. By achieving proper integration based on sound scientific principles, many development and production problems can be avoided. The course includes case studies of tablet formulation development and a detailed step by step analysis of all elements of the tablet manufacturing process.

    Upon completing the course, all participants will have a comprehensive understanding of the principles of formulation development and how they can be used to understand and troubleshoot manufacturing issues and problems, and improve productivity.


    Who Should Attend

    This course has been created to assist those involved in the formulation design of tablets and capsules including identifying and troubleshooting design and production issues that may arise. The course will be especially useful for those involved in:

    • Pre-formulation and Formulation development
    • Tablet and capsule product and process development
    • Tablet and capsule production troubleshooting support staff
    • Process Development who wish to extend their understanding of the relationship between formulation and process, and how formulations are selected in the real world
    • Regulatory and quality areas who need to improved understanding of tablet and capsule manufacturing technologies

    Attendees are encouraged to bring specific problems for the group to consider.

    Learning Objectives

    Upon completion of the course, attendees will understand:

    • The principles of formulation design and the relationship between formulation and process
    • Appropriate formulation selection based on Target Product Profiles and Critical Quality and Material Attributes (CQAs and SMAs)
    • How to get the formulation right first time, based on pre-formulation data
    • What can go wrong with a product – trouble shooting and Root Cause Analysis
    • The types of changes which will improve a poor product and how to evaluate them